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bioMerieux Inc.
San Jose, CA, United States
Description PRIMARY DUTIES During the initial phase of a product development process (PDP), the engineer plans and documents development of new processes following PDP procedure through change control. Contributes to the design and development of robust, reliable, effective and efficient processes. Owns new product introduction during pilot produc
Job Source: bioMerieux Inc.bioMerieux Inc.
San Jose, CA, United States
Description PRIMARY DUTIES During the initial phase of a product development process (PDP), the engineer plans and documents development of new processes following PDP procedure through change control. Contributes to the design and development of robust, reliable, effective and efficient processes. Owns new product introduction during pilot product
Job Source: bioMerieux Inc.BioFire Diagnostics
San Jose, CA, United States
PRIMARY DUTIES During the initial phase of a product development process (PDP), the engineer plans and documents development of new processes following PDP procedure through change control. Contributes to the design and development of robust, reliable, effective and efficient processes. Owns new product introduction during pilot production phase th
Job Source: BioFire DiagnosticsBioFire Diagnostics, LLC.
San Jose, CA, United States
PRIMARY DUTIES + During the initial phase of a product development process (PDP), the engineer plans and documents development of new processes following PDP procedure through change control. Contributes to the design and development of robust, reliable, effective and efficient processes. + Owns new product introduction during pilot production
Job Source: BioFire Diagnostics, LLC.BioFire Diagnostics, LLC.
San Jose
PRIMARY DUTIES + During the initial phase of a product development process (PDP), the engineer plans and documents development of new processes following PDP procedure through change control. Contributes to the design and development of robust, reliable, effective and efficient processes. + Owns new product introduction during pilot production phas
Job Source: BioFire Diagnostics, LLC.Palo Alto Networks, Inc.
Santa Clara, CA, United States
Our Mission At Palo Alto Networks everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is safer and more secure than the one before. We are a company built on the foundation of challenging and disrupting the way things are done, and we’re loo
Job Source: Palo Alto Networks, Inc.Arista
Santa Clara, CA, United States
Arista Networks is an industry leader in data-driven, client-to-cloud networking for large data center, campus and routing environments. What sets us apart is our relentless pursuit of innovation. We leverage the latest advancements in cloud computing, artificial intelligence, and software-defined networking to provide our clients with a competitiv
Job Source: AristaKLA
Milpitas, CA, United States
Base Pay Range: $111,300.00 - $189,200.00 AnnuallyPrimary Location: USA-CA-Milpitas-KLAKLA's total rewards package for employees may also include participation in performance incentive programs and eligibility for additional benefits identified below. Interns are eligible for some of the benefits identified below. Our pay ranges are determined by r
Job Source: KLASan Jose, CA, United States
PRIMARY DUTIES
During the initial phase of a product development process (PDP), the engineer plans and documents development of new processes following PDP procedure through change control. Contributes to the design and development of robust, reliable, effective and efficient processes.
Owns new product introduction during pilot production phase through successful and sustained project launch. This includes meeting new product introduction schedules, and resolving manufacturability issues.
Engineer may need to engage with equipment vendors to facilitate tool acquisition, installation, and qualification.
Must have the ability to succeed in a fast-paced environment: Be flexible and adaptable within a changing and dynamic environment with ambiguous scope.
Partner with cross functional teams to evaluate new product, processes, and equipment design at concept phase and define manufacturing processes.
Develop new and/or improved processes for parts and assemblies through the application of theoretical and practical engineering.
Extensive knowledge of equipment and methods to implement assembly and test processes of complex medical devices.
Coordinate and perform process characterization studies & DOE’s to develop process window and/or improve existing assembly processes.
Test, and validate new automation processes and/or designs in collaboration with a diverse functional team of engineers and scientists.
Write Verification/Validation protocols (IQ/OQ/PQ) and related technical reports to support the transfer of new products, processes, and equipment into production.
Perform failure investigations and root cause analyses as they relate to process performance.
Use statistical analysis, and hands-on bench or line testing to characterize attributes, process performance, and equipment assembly characteristics.
Create and/or update SOP/DOP and train MFG personnel to new processes and automated equipment during product transfer phase.
Drive data review and electronic documentation change control process
KNOWLEDGE, EXPERIENCE & SKILLS
Minimum Bachelor’s degree with 7+ years of relevant experience in medical device regulated manufacturing environment, or Master’s degree with 5 years of relevant work experience of relevant experience in medical device regulated manufacturing environment, or equivalent combination of education and experience to perform at this level
Demonstrated understanding of manufacturing processes including injection molding, machining, liquid dispensing, welding, design of experiments, and capability analysis
Hands-on experience with setting up, commissioning and optimization of manufacturing equipment.
Previous working experience supporting product development processes from initial state.
Previous working experience supporting medical device manufacturing lines.
Working knowledge of GMP, ISO, and FDA rules and regulatory requirements.
Hands-on mechanical and electro-mechanical troubleshooting skills of automated manufacturing equipment
Proven experience with DOE creation, root cause analysis, process engineering, failure investigations and automated assembly equipment.
Experience in process characterization and development, acceptance testing and qualification of automated equipment.
Working experience with 3D design packages (Solidworks, Inventor, Pro E)
Hands-on experience with semi-automated equipment troubleshooting, root cause analysis, equipment engineering, failure investigations and manufacturing assembly equipment.
Proven experience with mechanical design concepts, machinery and automation: Electrical, Mechanical, and Electromechanical schematics, motors, pumps, vacuum, and hydraulics
Experience with Quality Management System and electronic document change control required
Must have strong computer skills, including all MS Office applications, ERP system, learning portal and training
Must be proficient in document preparation and editing, including detailed test planning and report writing.
Excellent verbal and written communication skills to present summary data to cross functional team
Experience with statistical analysis software (JMP, MiniTab or similar)
Experience with updating BOMs, product specifications
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Email Alert for Associate Principal NPI Engineer jobs in San Jose, CA, United States
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